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An influenza pandemic is a real and significant potential threat facing the United States and the world. Pandemics occur when a novel virus emerges that can easily be transmitted among humans who have little immunity. In 2005, the Homeland Security Council (HSC) issued a National Strategy for Pandemic Influenza and, in 2006, an Implementation Plan. Congress and others are concerned about the federal government's preparedness to lead a response to an influenza pandemic. This report assesses how clearly federal leadership roles and responsibilities are defined and the extent to which the Strategy and Plan address six characteristics of an effective national strategy. To do this, GAO analyzed key emergency and pandemic-specific plans, interviewed agency officials, and compared the Strategy and Plan with the six characteristics GAO identified.

The executive branch has taken an active approach to help address this potential threat, including establishing an online information clearinghouse, developing planning guidance and checklists, awarding grants to accelerate development and production of new technologies for influenza vaccines within the United States, and assisting state and local government pandemic planning efforts. However, federal government leadership roles and responsibilities for preparing for and responding to a pandemic continue to evolve, and will require further clarification and testing before the relationships of the many leadership positions are well understood. The Strategy and Plan do not specify how the leadership roles and responsibilities will work in addressing the unique characteristics of an influenza pandemic, which could occur simultaneously in multiple locations and over a long period. A pandemic could extend well beyond health and medical boundaries, affecting critical infrastructure, the movement of goods and services across the nation and the globe, and economic and security considerations. Although the Department of Health and Human Services' (HHS) Secretary is to lead the public health and medical response and the Department of Homeland Security's (DHS) Secretary is to lead overall nonmedical support and response actions, the Plan does not clearly address these simultaneous responsibilities or how these roles are to work together, particularly over an extended period and at multiple locations across the country. In addition, the Secretary of DHS has designated a national Principal Federal Official (PFO) to facilitate pandemic coordination as well as five regional PFOs and five regional Federal Coordinating Officers. Most of these leadership roles and responsibilities have not been tested under pandemic scenarios, leaving it unclear how they will work. Because initial actions may help limit the spread of an influenza virus, the effective exercise of shared leadership roles and responsibilities could have substantial consequences. However, only one national multisector pandemic-related exercise has been held and that was prior to the issuance of the Plan. While the Strategy and Plan are an important first step in guiding national preparedness, they do not fully address all six characteristics of an effective national strategy. Specifically, they fully address only one of the six characteristics, by reflecting a clear description and understanding of problems to be addressed, and do not address one characteristic because the documents do not describe the financial resources needed to implement actions. Although the other characteristics are partially addressed, important gaps exist that could hinder the ability of key stakeholders to effectively execute their responsibilities, including state and local jurisdictions that will play crucial roles in preparing for and responding to a pandemic were not directly involved in developing the Plan, relationships and priorities among actions were not clearly described, performance measures focused on activities that are not always linked to results; insufficient information is provided about how the documents are integrated with other key related plans, and no process is provided for monitoring and reporting on progress.

Recommendations for Executive Action

Status: Closed - Not Implemented

Comments: In August 2012, HHS responded that while CDC continues to exercise its pandemic response capabilities and will conduct a functional exercise in September 2012, the exercise will not test the shared leadership roles and responsibilities between HHS and DHS. As a result, HHS and DHS have not provided information on shared leadership roles to state, local, and tribal governments; the private and nonprofit sectors; and the international community.

Recommendation: To enhance preparedness efforts for a possible pandemic, once the leadership roles have been clarified through testing, training, and exercising, the Secretaries of Homeland Security and Health and Human Services should ensure that these roles are clearly understood by state, local, and tribal governments; the private and nonprofit sectors; and the international community.

Agency Affected: Department of Homeland Security

Status: Closed - Not Implemented

Comments: In August 2012, HHS stated that while CDC continues to exercise its pandemic response capabilities and will conduct a functional exercise in September 2012, the exercise will not test the shared leadership roles and responsibilities between HHS and DHS. As a result, HHS and DHS have not provided information on shared leadership roles to state, local, and tribal governments; the private and nonprofit sectors; and the international community.

Recommendation: To enhance preparedness efforts for a possible pandemic, once the leadership roles have been clarified through testing, training, and exercising, the Secretaries of Homeland Security and Health and Human Services should ensure that these roles are clearly understood by state, local, and tribal governments; the private and nonprofit sectors; and the international community.

Agency Affected: Department of Health and Human Services

Status: Closed - Not Implemented

Comments: In our June 2011 report on H1N1 lessons learned, we noted that the shared leadership roles and responsibilities between HHS and DHS were not fully tested during the 2009 H1N1 influenza pandemic. At that time, we reported that HHS officials had told us that they were planning to exercise such roles with DHS. In August 2012, HHS followed-up on the status of this exercise. HHS stated that while CDC continues to exercise its pandemic response capabilities and will conduct a functional exercise in September 2012, the exercise will not specifically address our recommendation on conducting rigorous testing, training, and exercises to test the leadership roles and responsibilities between HHS and DHS. In addition, DHS informed us of CDC's September 2012 exercise.

Recommendation: To enhance preparedness efforts for a possible pandemic, the Secretaries of Homeland Security and Health and Human Services should work together to develop and conduct rigorous testing, training, and exercises for pandemic influenza to ensure that federal leadership roles are clearly defined and understood and that leaders are able to effectively execute shared responsibilities to address emerging challenges.

Agency Affected: Department of Health and Human Services

Status: Closed - Not Implemented

Comments: In our June 2011 report on H1N1 lessons learned, we noted that the shared leadership roles and responsibilities between HHS and DHS were not fully tested during the 2009 H1N1 influenza pandemic. At that time, we reported that HHS officials had told us that they were planning to exercise such roles with DHS. In August 2012, HHS followed-up on the status of this exercise. HHS stated that while CDC continues to exercise its pandemic response capabilities and will conduct a functional exercise in September 2012, the exercise will not specifically address our recommendation on conducting rigorous testing, training, and exercises to test the leadership roles and responsibilities between HHS and DHS. In addition, DHS informed us of CDC's September 2012 exercise.

Recommendation: To enhance preparedness efforts for a possible pandemic, the Secretaries of Homeland Security and Health and Human Services should work together to develop and conduct rigorous testing, training, and exercises for pandemic influenza to ensure that federal leadership roles are clearly defined and understood and that leaders are able to effectively execute shared responsibilities to address emerging challenges.

Agency Affected: Department of Homeland Security

Status: Closed - Not Implemented

Comments: The Homeland Security Council did not initially comment on this recommendation when the report was issued. In February 2009, we again reported that HSC had not commented on the recommendation and had not indicated if it planned to implement it. We reiterated this recommendation in our November 2009 report on the National Pandemic Implementation Plan status. We followed-up as a part of our engagement on lessons learned from the H1N1 pandemic and the White House Homeland Security Council's National Security Staff (NSS) informed us in April 2011 that the NSS does not plan on updating the National Pandemic Strategy or the National Pandemic Implementation Plan.

Recommendation: The Homeland Security Council should establish a specific process and time frame for updating the Implementation Plan for the National Strategy for Pandemic Influenza. The process for updating the Plan should involve key nonfederal stakeholders and incorporate lessons learned from exercises and other sources. The Plan should also be improved by including the following information in the next update: (1) the cost, sources, and types of resources and investments needed to complete the action items and where they should be targeted; (2) a process and schedule for monitoring and publicly reporting on progress made on completing the actions; (3) clearer linkages with other strategies and plans; and (4) clearer descriptions of relationships or priorities among action items and greater use of outcome-focused performance measures.